VSXE One 14732

GUDID E217147321

VSXE One Intro pack

Kettenbach GmbH & Co. KG

Silicone dental impression material

• Primary Device ID: E217147321
• NIH Device Record Key: 745c3120-bd8e-4306-b4bb-39611030f210
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VSXE One
• Version Model Number: 14732
• Catalog Number: 14732
• Company DUNS: 316803246
• Company Name: Kettenbach GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E217147321 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092867

FDA Product Code

• ELW: Material, Impression

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-07
• Device Publish Date: 2023-05-30

On-Brand Devices [VSXE One]

• E217147331: VSXE One Refill pack
• E217147321: VSXE One Intro pack